ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development)

ASCEND（儿童 ARDS 和 ECMO 启动策略对神经发育的影响）

• 批准号: 10468145
• 负责人: Ryan Barbaro
• 金额: $ 62.3万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468145
• 关键词: Acute; Acute Respiratory Distress Syndrome; Address; Age; Anticoagulation; Blood; Brain; Breathing; Cannulas; Child; Child Support; Childhood; Clinical; Clinical Trials; Communication; Consequentialism; Critically ill children; Data; Data Collection; Data Element; Equipoise; Evaluation; Extracorporeal Membrane Oxygenation; Failure; Family; Fatigue; Funding; Guidelines; Hemorrhage; High-Frequency Ventilation; Impairment; Intervention; Knowledge; Lead; Life; Longitudinal prospective study; Measures; Mechanical Ventilators; Mechanical ventilation; Morbidity - disease rate; Motor; National Heart, Lung, and Blood Institute; Nervous System Trauma; Nutritional Support; Organ failure; Outcome; Outcome Study; Oxygen; Patient-Focused Outcomes; Pediatric Acute Respiratory Distress Syndrome; Positioning Attribute; Prone Position; Protocols documentation; Pump lung; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Registries; Sensory; Site; Stroke; Supination; Support Groups; Techniques; Testing; Uncertainty; Ventilator; Ventilator-induced lung injury; artificial lung; blood pump; comparative effectiveness study; conventional therapy; experience; functional outcomes; functional status; health related quality of life; instrument; mental state; mortality; neurodevelopment; preservation; prospective; respiratory; response; systematic review; treatment as usual; ventilation

Project Abstract Decades after extracorporeal membrane oxygenation (ECMO) was first used to support children with severe pediatric acute respiratory distress syndrome (PARDS), pediatric intensivists lack both prospective studies of long-term outcomes in ECMO for PARDS and well-powered studies comparing the impact of ECMO initiation strategies on mortality and morbidity. While clinicians lack the equipoise necessary to randomize ECMO in dying children, there is uncertainty on if and when it is best to initiate ECMO to preserve survival, functioning, and quality of life. To answer the question, if and when ECMO should be initiated in children with severe PARDS, it is necessary to compare the long-term outcomes in ECMO supported children to otherwise similar children who did not receive ECMO at the same threshold if at all. An opportunity to address this question is provided by NHLBI-funded Prone and Oscillation Pediatric Clinical Trial (PROSpect) and the ECMO registry, Extracorporeal Life Support Organization (ELSO). PROSpect is a randomized clinical trial testing the impact of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation on short and long-term clinical outcomes in 1,000 children with severe PARDS. PROSpect manages subjects with a rigorous protocol that reserves ECMO for protocol failure. The ELSO Registry includes children receiving usual care ECMO, initiated at the discretion of the intensivist. ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development) will harmonize PROSpect and ELSO data collection and prospectively measure long-term functional status and quality of life in 550 children with severe PARDS from ELSO sites. ASCEND will then match children in both groups on their propensity to receive usual care ECMO. ASCEND combines real-world observational data (from ELSO) and a randomized clinical trial (from PROSpect) by matching similarly critically ill children treated under usual care ECMO or a rigorous ventilation protocol that reserves ECMO for protocol failure. Our specific aims include: Aim 1: We will test the hypotheses that one year after children receive usual care ECMO for PARDS, there will be a decline in long-term functional status and health-related quality of life as well as an increase in the proportion of children receiving respiratory support. Aim 2: We will test the hypotheses that 90-day mortality, one-year functional status, and one-year health- related quality of life are not equivalent for children with usual care ECMO (in ELSO) and PROSpect's protocolized therapies.

项目摘要 在体外膜氧合(ECMO)首次用于支持重症儿童几十年后 儿科急性呼吸窘迫综合征(PARDS)，儿科强化治疗缺乏对 PARDS患者ECMO治疗的长期结果和比较ECMO治疗效果的有效研究 关于死亡率和发病率的战略。虽然临床医生缺乏将ECMO随机化所需的平衡 对于濒临死亡的儿童，是否以及何时启动ECMO以保护生存、功能、 和生活质量。为了回答这个问题，是否以及何时应该对患有重症的儿童启动ECMO Pards，有必要将ECMO支持的儿童的长期结果与其他相似的儿童进行比较 没有接受ECMO的儿童如果有的话，也是在相同的门槛下接受ECMO。 NHLBI资助的俯卧和振荡儿科临床提供了解决这个问题的机会 试验(PROCESS)和ECMO登记，体外生命支持组织(ELSO)。潜在客户是一种 随机临床试验测试仰卧/俯卧姿势和传统机械姿势的影响 呼吸机/高频振荡呼吸机对1000例慢性阻塞性肺疾病患儿近期和远期临床疗效的影响 严厉的扑克牌。Prospects使用严格的协议管理对象，为协议故障保留ECMO。 ELSO登记处包括接受常规护理的儿童，ECMO是由强化治疗者酌情发起的。 ASCED(儿童ARDS和ECMO启动策略对神经发育的影响)将协调一致 前景和ELSO数据收集和前瞻性测量长期功能状态和生活质量 在550名来自ELSO站点的患有严重Pard的儿童中。然后，Ascend将匹配两个组中的孩子 接受常规护理的倾向ECMO。Ascend结合了真实世界的观测数据(来自ELSO)和一个 随机临床试验(来自PROSPECT)，配对在常规护理下接受治疗的类似危重儿童 ECMO或为协议故障保留ECMO的严格通风协议。我们的具体目标包括： 目标1：我们将检验以下假设：在儿童接受帕德的常规护理ECMO一年后，将会有 长期功能状态和与健康相关的生活质量下降，以及 接受呼吸支持的儿童比例。 目标2：我们将测试90天死亡率、一年功能状态和一年健康状况的假设- 接受常规护理的儿童的相关生活质量并不等同于ECMO(ELSO)和Prospects的 原始化疗法。